The Predictive Value of Non-Clinical Testing

5. Toxicology Studies

5.4. Genotoxicity Studies

Genotoxicity studies test the effect of the medicine on the chromosomes and genes. They are generally needed to support human safety. Assessment ofgene mutations, is considered enough to support all single-dose clinical trials. For multiple-dose clinical trials, an additionalassessment of chromosomal damage in mammalian systems must be performed. In addition, a full battery of tests for genotoxicity should be completed before Phase II clinical trials. If the test results show genotoxicity, additional testing must be considered.